FDA 510(k) Application Details - K052086

Device Classification Name

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510(K) Number K052086
Device Name ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER
Applicant ENCORE MEDICAL, INC.
9800 METRIC BLVD.
AUSTIN, TX 78758 US
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Contact CHRISTIE SHUMAKER
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Regulation Number

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Classification Product Code PHX
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Date Received 08/02/2005
Decision Date 08/31/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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